Genervon - GM6 - An opportunity to communicate with the FDA
- Thread starter rknt50a
- Start date
- Status
- Joined
- Feb 23, 2014
- Messages
- 2,636
- Reason
- Lost a loved one
- Diagnosis
- 01/2014
- Country
- US
- State
- NC
- City
- Littleton
Yes, congratulations! Please tell her she's a special lady1
Lilacs53
Distinguished member
- Joined
- Oct 13, 2014
- Messages
- 107
- Reason
- PALS
- Diagnosis
- 09/2014
- Country
- US
- State
- AZ
- City
- Buckeye
FrenchFries
Member
- Joined
- Jun 17, 2014
- Messages
- 29
- Reason
- Other
- Country
- FR
- State
- Paris
- City
- Paris
On ALSA.org, published yesterday:
http://www.alsa.org/news/archive/response-to-genervon-drug.html
The ALS Association Responds to Inquiries on Genervon Drug Candidate
January 19, 2015
Numerous individuals have contacted The ALS Association requesting assistance in the promotion of patient access to a drug candidate called GM6 in development by Genervon Biopharmaceuticals LLC.
Genervon recently issued a press release regarding its submission of results to the U.S. Food and Drug Administration (FDA) of its single patient compassionate use trial for GM6. The company had announced the results of their Phase 2A clinical trial of the drug in October 2014.
The ALS Association has engaged Genervon to learn more about the trial results and the company’s plans for moving forward with the FDA and clinical development. Those discussions will inform next steps and what role The Association will play as the drug advances in the development process.
As always, The ALS Association is committed to doing everything possible to advance therapies for ALS, working closely with pharmaceutical companies and the U.S. Food and Drug Administration.
Facebook:
The ALS Association has heard from many of you regarding the drug candidate from Genervon. We have engaged the company to learn more about the trial results and its plans for moving forward with FDA and clinical development. The Association is committed to doing everything possible to advance therapies for ALS, working with pharmaceutical companies and the FDA to do so. We’ll continue to keep everyone updated as we dialogue with Genervon. Read more here.
http://www.alsa.org/news/archive/response-to-genervon-drug.html
The ALS Association Responds to Inquiries on Genervon Drug Candidate
January 19, 2015
Numerous individuals have contacted The ALS Association requesting assistance in the promotion of patient access to a drug candidate called GM6 in development by Genervon Biopharmaceuticals LLC.
Genervon recently issued a press release regarding its submission of results to the U.S. Food and Drug Administration (FDA) of its single patient compassionate use trial for GM6. The company had announced the results of their Phase 2A clinical trial of the drug in October 2014.
The ALS Association has engaged Genervon to learn more about the trial results and the company’s plans for moving forward with the FDA and clinical development. Those discussions will inform next steps and what role The Association will play as the drug advances in the development process.
As always, The ALS Association is committed to doing everything possible to advance therapies for ALS, working closely with pharmaceutical companies and the U.S. Food and Drug Administration.
Facebook:
The ALS Association has heard from many of you regarding the drug candidate from Genervon. We have engaged the company to learn more about the trial results and its plans for moving forward with FDA and clinical development. The Association is committed to doing everything possible to advance therapies for ALS, working with pharmaceutical companies and the FDA to do so. We’ll continue to keep everyone updated as we dialogue with Genervon. Read more here.
Nikki J
Moderator
- Joined
- Mar 22, 2012
- Messages
- 16,459
- Reason
- PALS
- Diagnosis
- 04/2014
- Country
- US
- State
- MA
- City
- Boston
This is a comment by alstdi staff on their thoughts. Genervon Clinical Trial Update | ALS Therapy Development Institute
Marv
New member
- Joined
- Apr 10, 2014
- Messages
- 3
- Reason
- PALS
- Diagnosis
- 05/2012
- Country
- CA
- State
- Sask.
- City
- Somewhere
This is my send to FDA
FDA Health and Human Services.
I am a ALS Victim, legs gone, arms use 20%, voice and swallowing 50%, trunk 20% and need to be cared for 90% of the time.
In 1996 ALS Victims where offered a drug solution to there problem called Rilutek. Take 1. morning and 1. at night and we the FDA will allow you to suffer 3 months longer.
18 years later Genervon comes up with research and then a 12 person trial that shows safety and results and the ALS Society is worried the FDA is going to hold this treatment / research up for how many more years?
I / We know that a person dies every 90 min of ALS and there is no time to waste. Fast Track, Orphan Drug Status, Expanded Access what ever it takes to get this drug to the Victim should have been done Yesterday not tomorrow or the next day.
FDA Health and Human Services.
I am a ALS Victim, legs gone, arms use 20%, voice and swallowing 50%, trunk 20% and need to be cared for 90% of the time.
In 1996 ALS Victims where offered a drug solution to there problem called Rilutek. Take 1. morning and 1. at night and we the FDA will allow you to suffer 3 months longer.
18 years later Genervon comes up with research and then a 12 person trial that shows safety and results and the ALS Society is worried the FDA is going to hold this treatment / research up for how many more years?
I / We know that a person dies every 90 min of ALS and there is no time to waste. Fast Track, Orphan Drug Status, Expanded Access what ever it takes to get this drug to the Victim should have been done Yesterday not tomorrow or the next day.
hjlindley
Senior member
- Joined
- Dec 1, 2011
- Messages
- 761
- Reason
- PALS
- Diagnosis
- 10/2011
- Country
- US
- State
- VA
- City
- Richmond
I'm going to be the Debbie downer here. Phase 1 is done for safety but is not normally done at patient population for which the drug is intended. Phase 2 was extremely small. We don't have proof that her work in our population and no one knows for sure that it's safe for an ALS patient . I was in a clinical trial that had serious side effects and if I continued on the Trial drug it may well have killed me. We have no statistical proof that this works or is safe. Many people misunderstand and believe that phase I safety trials are done in the targeted patient population. They are not.I do want effective treatment but I'm not willing to risk what health I have left on a drug was so little known about it.
Janie H
Senior member
- Joined
- Jun 23, 2013
- Messages
- 714
- Reason
- PALS
- Diagnosis
- 06/2013
- Country
- US
- State
- South Carolina
- City
- Rock Hill
I am close to 2 years into this nightmare. I would be willing to take my chances. My family and friends have gotten thousands of signatures. I was a member of the local board of realtors before I was disabled, we are going to them tomorrow, could be a lot more people to sign.
Janie
Janie
- Status
Similar threads
- Locked
